Make in India – What does it mean for the pharma and Biotech Industry

The ‘Make in India’ initiative of the Government of India is to focus on 25 sectors of the economy for job creation and skill enhancement.
Some of these sectors are automobiles , chemicals, I.T, pharma, biotechnology, textiles, ports, aviation, leather, tourism, railways, renewable energy, mining, etc.,

The Indian Pharmaceutical Industry

The pharma industry in India is the third largest in terms of volume and thirteenth largest in terms of value and dominated by branded generics which constitute nearly 70% to 80% of the market. India has achieved an eminent global position in the pharma sector by virtue of its huge pool of scientists. The industry is estimated to grow at 20% compounded annual growth rate over the next five years.

Challenges

Apart from the problem of competing with countries like China, Korea and Malaysia, the other challenges faced by the Indian Pharma industry are:-

Drug quality

According to WHO estimates, 30% of Branded drugs sold in the developing is counterfeit. The Government of India has taken steps to counter this by upgrading the State Drug Testing laboratories with modern technology and the latest testing equipments, enforcing serialization, non clone able packaging and 2D bar coding and increasing the number of new drug manufacturer inspectors.

Clinical Trial quality

In effective regulation of clinical trials leading to unethical practices in conducting clinical trials. The Government of India, after the Supreme Court directions had constituted the Dr. Ranjit Roy Chaudhury expert committee and its recommendations are in the process of being implemented.

Patent Issues and Drug pricing policies in the market

The promotion of generic products and the Drug Pricing policies of the Health Ministry to prevent prices of life saving drugs from becoming unaffordable to the common man have caused a number of issues to Multinational companies who are questioning the commercial viability of India as a profitable destination for clinical trial

Government’s initiative to promote the Indian Pharma Industry

Indian and global companies have expressed intent for 175 investments worth Rs. 1000 cr. in Gujarat

Telengana Government has proposed to set up India’s largest integrated pharmaceutical city spread over 1100 acres near Hyderabad in a bid to attract investments of Rs. 30, 000 cr.

The Road Ahead

Indian pharma Industry is expected to grow to US$ 85 billion by 2020. The Government is taking several cost effective measures in order to bring down Health care expenses by speedy introduction of generic drugs, thrust on rural health programs, life saving drugs and preventive vaccines and health insurance for all.

However, all the above initiatives are only proposed by the Government and may take years to be implemented. The ground reality is that the pharma industry has not seen any concrete steps taken by the Government to put the pharma industry back on track and the road to recovery.

Meanwhile, many multinational companies unhappy with the Government’s Drug pricing policies and promotion of generic drugs have left India for countries like Korea, Malaysia and some African countries having easier regulatory policies and speedier sanctions. Even Indian companies like Biocon and others have shifted their clinical trials to Malaysia and Korea due to the new regulatory norms and inordinate delay in according sanctions.

In conclusion, for the Indian Pharmaceutical Industry, ‘Make in India’ is just a slogan and the multinational companies leaving India is a clear signal that they are not investing in India until the Government comes up with easier and clearer regulatory policies and faster sanctions.

Indian Biotech Industry

The past one decade has seen the Indian biotech industry growing from strength to strength. Being one of the top ten destinations in the world, Indian biotech sector has expertise and is leading in vaccines and agri-biotech. Some of the companies specialize in bio-pharmaceuticals and are leading in the world.

However, the major areas in biotech sector, viz., Biosimilars, Vaccines and Stem cells require smooth regulatory framework and guidelines that would help in trials and development.

Some of the Highlights:

Market size -2% of the global biotech industry

Ranked 12th in the World and 3rd in Asia Pacific

Comprises of about 400 companies and worth US$ 4 billion

Average growth rate of 20% and poised to reach US$ 7 Billion by 2015

Major Initiatives by Govt. of India

CSIR – Institute of Himalayan Bioresource Technology has signed MOU to transfer of technology in cosmetic, food, and pharma industries for end applications.

DBT has allocated Rs 4.6 crores to University of Agricultural Sciences to support a national multi-institutional project titled ‘A value chain on jackfruits and its products

Under the 12th five year plan to set up Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certifications.

Road ahead

With an annual investment of US$ 4.019 million to US$ 5.024 million, in the next five years the biotech industry can grow to US$ 100 million by 2025 with a 25% return on investment and a growth rate of 30% year on year. With the support and initiatives of the Govt of India the industry can attain global leadership in providing affordable health care and innovative medicines and quality food for all.

In response to Prime Minister Narendra Modi’s plan of making it easier to do business in India, the Health Ministry proposed pre submission meetings between the Drug Regulators and the Drug manufacturing companies before formal applications for clinical trials. This move is expected to increase transparency, predictability and accountability.

(From the Desk of S G B Rao,Publisher, LSW LifeScienceWorld)

LSW sought views from some experts related to the industry and here is what they have to say :

“Make in India” in Bio-Pharmaceutical Industry:India is a natural reservoir of scientific talent, entrepreneurial spirit and creative mindset. These are basic ingredients necessary for successfully enhancing our already well established manufacturing capabilities in the bio-pharmaceutical sector in the country. This is also an era of scientific collaboration by way of technology partnerships and being part of the value chain for discovery, development and manufacturing of bio-pharmaceuticals. We live in a world of multi-disciplinary, multi-cultural and multi-country collaboration and India has to recognize that, in such a milieu, we need to compete with other countries for resources and technologies.Bio-pharmaceutical companies are expecting – at the minimum – the following three areas where we have to make tangible and strong progress through action.
Government’s firm commitment to making procedures and systems, that make doing business in India easier,including quick clearance of FDI proposals, Clinical trials processes and single window approvals as well as transparency in all dealingsCreate stability in doing business in India. Government’s frequent interference in imposing price-controls, after a stringent review of National List of Essential Medicines only a few years ago, has brought about uncertainty and lack of trust among investors. We must resist the temptation to penalize the Indian Pharma Industry with further price cuts, when an already vibrant and highly competitive pharma industry has kept a check on prices across the spectrum of medicines and vaccines.Actively promote India’s commitment to Intellectual property Rights – respect for innovation. This will help motivate top notch Global companies to set up partnerships and shops to discover and develop in India, for Indian patients.——————————————————————————————————————————————————————

Sujay ShettyPharma Life Sciences Leader, India PriceWaterhouseCoopers

Make in India is certainly possible for Pharma. India can produce high quality, affordable drugs for the world. As an example- India supplies over 30 percent by volume of the US generic market and has has a large number of USFDA approved plants – second only to US. Similarly, India is a significant exporter to Africa, Latin America, CIS and other parts of Asia.——————————————————————————————————————————————————————

Dr. Murtaza Khorakiwala Managing Director

“Wockhardt Limited”The Indian Pharmaceutical industry is an outstanding example of PM Modi’s ‘Make in India’ vision. Products manufactured in India had less than 2% Market share of of medicines consumed in U.S at the beginning of the century. Today 15 years later products made in India represent more than 20% of medicines consumed in the U.S and U.S. represents more than 40% of global Pharma market. This is a clear demonstration of Indian entrepreneurship, competitiveness on global scale, knowledge and skill and transformation possible by Indian companies.”

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Prof. Sudip Chaudhri Economics

Indian Institute of Management, Calcutta”Make in India” initiative is a timely and extremely important initiative. While Economic Reforms have brought about significant changes in the Indian economy, it has failed to stimulate the manufacturing sector. For promoting the sector, government needs to specifically intervene and support the industry. Pharmaceutical industry is one of the more developed industries in India today and what needs to be done here is quite different from what needs to be done for less developed industries such as computer hardware and medical devices.

So far as the pharmaceutical industry is concerned, I would like to comment here on one important weakness of the industry. The types of skills and technical competence required for developing a biotechnology drug is different from what is required for traditional chemical drugs. The Indian generic companies at the current stage are less proficient in the former compared to the latter. For the future growth of the industry this weakness needs to be corrected. Government not only needs to directly support innovation in this area. Government also needs to put in place supportive regulations to develop the generics companies. Regulatory guideline is a technical matter. But what is also important to appreciate is that regulations can also act as a barrier and can make the entry of generics difficult. It is important for India to develop her own standards. Rather than the government acting as a regulator and private industry a developer, the two should join hands. India has the necessary technical expertise in the area both in the public and private sectors. Government needs to identity a few important biotechnology drugs for development. And these drugs need to be developed on a mission mode with clear objectives and targets, time frame and plan of action. Such experiments can help not only in promoting technology but also in developing regulatory guidelines more suitable for India.